U.S. Promotion of Ag Biotech in Egypt

U.S. Promotion of Ag Biotech in the Egypt began in October 1992 with a project by the Agricultural Biotechnology Support Project (ABSP) I (ABSP I) at Michigan State University under the Commercialization and Utilization of Biotechnology (CUB) Project, funded by USAID's Cairo office.[1] The project was aimed to meet USAID's goals for Egypt, namely "accelerated private sector-led, export oriented economic growth." To do this, it worked to "improve the capacity and policy environment for the use, management, and commercialization of agricultural biotechnology in Egypt." Cornell University, Pioneer Hi-Bred, and Egypt's Agricultural Genetic Engineering Research Institute (AGERI) also collaborated in the project. Among other things, the project worked on creating Bt potato tuber moth-resistant potatoes.

By 2007, Egypt still had no commercialized GMOs, although it was working on commercializing four: potatoes, squash, yellow and white maize, and cotton.[2] In 2008, Egypt commercialized Bt corn and Bt cotton[3]

ABSP I Project in Egypt

Project Background

"ABSP’s main collaborator in this project has been the Agricultural Genetic Engineering Research Institute (AGERI), part of the Egyptian Agricultural Research Center (ARC). AGERI was jointly established by the Egyptian government and the United Nations Development Program in 1989, with the aim of using genetic engineering to develop crops with enhanced traits, such as disease and insect resistance and salt and drought tolerance. A high level of support from the Egyptian government for biotechnology research has enabled AGERI to develop state-of-the-art laboratories, presenting an ideal opportunity to enhance the training of many individuals in the country since the basic infrastructure and capacity was already in existence."[1]

"The grant entered into by ABSP and AGERI focused toward the ultimate goal of production of a variety of selected crops (initially specifically potatoes, maize, cucurbits and tomatoes) that showed resistance to major economic pests and diseases in Egypt. Since 1993, ABSP’s collaboration with AGERI has continued to evolve in applied research and has also examined the important policy areas of biosafety and Intellectual Property Rights. In addition to its product-oriented focus, the collaboration has explored appropriate technology transfer, human resource development and links between the public and private sectors in both countries. The project has thus encompassed research, policy, networking and management aspects of biotechnology."[1]

Toward these ends, Egypt "adjusted its national intellectual property rights (IPR) policies to include the patenting of food and plant products. A Plant Variety Protection law (PVP) is pending the approval of the Egyptian parliament. Egypt has approved biosafety guidelines and developed an effective framework with which to enforce these guidelines. The scientists at AGERI have developed awareness of the importance of IPR, biosafety and technology transfer policies and their implementation both at the
national and institutional level. AGERI scientists have been successful in the development of transgenic plants, which have been tested in the greenhouse and fields for research purposes." A 2002 report concluded that "These impressive achievements now set an excellent stage for the future commercialization of the products of agricultural biotechnology in Egypt."[1]

USAID lists the project's achievements as:

"Transgenic potatoes developed and successfully field-tested in Egypt.

"Transgenic and traditionally bred cucurbits developed and successfully field-tested in Egypt.

"Development and adoption of biosafety regulations in Egypt.

"National Biosafety Committee established, biosafety review system in place and functioning.

"Research collaborations developed successfully with the private sector (Pioneer Hi-Bred)."[1]

Project Timeline

May 1993: Seven Egyptian scientists visit the U.S. for an eight week Biosafety Internship Program held at Michigan State University, including a trip to Washington D.C. to meet with staff at USDA, FDA, and EPA.

1993: Interns from Egypt, Kenya, and Indonesia attend a Intellectual Property/Patent Internship Program at Stanford University, designed and implemented by John Barton of the Stanford Law School.

January 1994: A biosafety workshop is held at AGERI. ABSP's Biosafety Consultant Patricia Traynor attends. A Workshop On Intellectual Property Rights, Patents & Licensing, designed by John Barton is held in Cairo, Egypt. It is attended by 100 participants "from various public and private sector institutions" including "scientists, legal professionals and government officials from Egypt."

1995:

ABSP worked with AGERI to subcontract greenhouse construction in Egypt to the University of Arizona. "Certification of the containment facility was authorized by the Chief of Microorganisms Branch at the USDA/APHIS/BBEP. As well as being the first of its type in Africa (outside South Africa), the AGERI biocontainment facility was a model for the facility subsequently constructed in Indonesia through World Bank funding."

A National Biosafety System was instituted by the Ministry of Agriculture and Land Reclamation. This was done through two decrees: Ministerial Decree No. 85 (January 25, 1995), which established a National Biosafety Committee (NBC); and Ministerial Decree No. 136 (February 7, 1995), which adopted biosafety regulations and guidelines for Egypt.

ABSP and AGERI hold a two-day seminar on the legal framework for technology transfer and intellectual property rights. Over 100 representatives from government and private sector institutions in agriculture and the pharmaceutical industry attended the workshop.

December 1997: Karim Maredia, ABSP's Technology Transfer Coordinator, traveled to Egypt to finalize plans for the first field test of the Potato tuber moth (PTM) resistant Bt transgenic potato and to facilitate the signing of the Material Transfer Agreement. That month, the permit application for the field-testing of the potatoes was approved by the Egyptian National Biosafety Committee (NBC).

May 1998: ABSP holds a project evaluation workshop in Cairo. Egyptian and US scientists to present their collaborative research work. Pioneer Hi-Bred, Aventis, Seminis, and Hy-Tec all attend.

1998-2002: ABSP works with Zeneca and Syngenta in IPR negotiations for the Cry5 Bt gene, which is utilized in the MSU potato tuber moth resistant potatoes.

1999: "Through IPR training provided in Cairo in April 1999 for Professor Ibrahim Siddik, Vice President for Community Services, the Menoufia University in Egypt established a new IPR Center in the Faculty of Law."

May 1999: Egyptians Magdy Madkour and Mohamed Eid visit Michigan State University and meet with MSU's Office of Intellectual Property Rights. "Based on the information provided during their visit, Dr. Eid has drafted an Intellectual Property Rights (IPR) policy for the Agricultural Genetic Engineering Research Institute (AGERI). A copy of this policy has been sent to MSU for review and comments, and forwarded to USAID. The IP policy will serve as the basis for the technology transfer program at AGERI and eventually all the agricultural research centers in the Ministry of Agriculture."

1999-2001: University California Berkeley's Haas Business School, brought on board by ABSP, evaluates and analyzes AGERI to assist it in privatization.

1999-2002: Michigan State University (MSU) conducts a one-week short course with a focus on food safety policy development, risk analysis, and program implementation. ABSP sends several participants from Egypt.

May 2000: AGERI and ABSP jointly hold a Commercialization and Utilization of Biotech (CUB) Symposium in Egypt, funded by USAID. "Thirty participants traveled to the symposium from the U.S. and Europe. The ABSP management team and researchers from Michigan State University attended the symposium along with ABSP sub-contract researchers from several U.S. universities, U.S. government officials, non-profit organizations, and private industry from the U.S. and Europe. About 40-50 Egyptian researchers, institute and government officials and Egyptian private industry representatives attended the 4-day symposium."

Fred Erbisch completed an Intellectual Property ‘audit’ of MSU’s potato tuber moth resistant B.t. potatoes. "This is another step in the process of obtaining legal clearances to commercialize MSU’s transgenic potatoes in Egypt and South Africa, as well as any other developing countries."

"The Office of Technology Transfer and Intellectual Property (OTTIP) at AGERI was established. Internal IP policy was developed and approved. A model Material Transfer Agreement (MTA), a License Agreement and a Confidential Disclosure Agreement were developed, based on MSU Office of Intellectual Property forms, in both English and Arabic and a comprehensive awareness program for AGERI staff was implemented."

OTTIP helped develop an IP policy for the Agricultural Research Center (ARC).

September 2001: Fred Erbisch and Karim Maredia developed and participated in two additional short-term training programs at Michigan State University. "One program was on intellectual property management and was presented to 9 representatives from the Egyptian ARC [Agricultural Research Center]. The ARC will now establish a technology transfer office in Egypt that the September workshop participants will operate. The second training program dealt with plant variety protection (PVP) and was attended by 8 senior representatives from the ARC. Participants of this workshop will be staffing the Egyptian PVP Office.

Biosafety Laws

The U.S. set a goal of "establishment of a policy framework in Egypt that promotes the use, management and commercialization of biotechnology."[1] This was important to the U.S. because, within the ABSP I project, "before any genetic transformation technology or materials may be transferred, the recipient country must have in place a regulatory approval mechanism to insure the safe transfer, handling and permitting of transgenic materials."[1]

Egypt established Biosafety laws with two decrees in 1995, followed by one in 1998 to allow for the commercialization of GMOs. With the regulatory framework in place, the following GMOs were field tested in Egypt: Insect-resistant potatoes (MSU and AGERI); Virus resistant squash (AGERI); Virus resistant tomatoes (AGERI); and Bt resistant maize (Fine Seeds/Novartis, Pioneer Hi-Bred).

Intellectual Property Laws

" From its inception, the ABSP has supported capacity building and policy assistance in Intellectual Property Rights (IPR) and technology transfer. In the design of the ABSP, USAID realized that new technological breakthroughs, private investment, and governmental protection of intellectual property were spurring agricultural biotechnology in developed countries. This has led to a changed institutional structure of agricultural research with a greater collaboration between public institutions and private biotechnology companies...

"The ABSP has taken a number of approaches to intellectual property issues, at the national and institutional level in Egypt. The ABSP philosophy has been to provide information and training, and facilitate countries and institutions in the development of their own strategies, policies and procedures to access proprietary technology. The ABSP has held one-on-one consultations, workshops, and internships to provide assistance to Egypt. Additionally, ABSP has sponsored participation to international meetings and access to news and information on IPR via the World Wide Web. Capacity building in IPR is one of the areas in which the ABSP has achieved unique success, and can serve as an effective model for other programs in agricultural biotechnology and development."[1]

Commercialization and Institution Building

"One of the overall goals of the Commercialization/Technology Transfer/Institution Building portion of the initial proposal was to assist AGERI in long-term strategic planning and in developing a vision and plan for sustainable growth." USAID's Cairo office suggested that AGERI should consider privatization. They provided private sector management consultants to "assist AGERI in transitioning from a public-sector research institute to a more commercially operating unit." It also provided funds to help AGERI develop "privatization feasibility studies and a long-term strategic plan for the sustainability of AGERI, post-USAID support." This was conducted by University of California Berkeley’s Haas Business School. ABSP also "[engaged] a biotechnology business consultant to assist AGERI in implementing its strategic plan."[1]

In 1999, one team from Haas examined AGERI's finances and made a number of recommendations based on their research. In 2000, a second team, "under the guidance of Drs. Catherine Ives, Director, ABSP and Magdy Madkour, Director, AGERI," created a strategic marketing plan for AGERI. They recommended AGERI: "1) advance a market-driven philosophy; 2) expand management capability; 3) build strategic partnerships, especially through the local seed industry; 4) expand external communication efforts; 5) select the highest potential crops and traits; 6) evaluate projects based on a market-based metric; 7) promote international standards of intellectual property protection (IPR) and biosafety regulation; 9) encourage a public awareness campaign, and 9) grow the underutilized GESU (the Genetic Engineering Services Unit at AGERI) as an additional source of revenue."

In 2001, a third team from Haas worked on "preparing AGERI for continued success in the evolving biotechnology industry." They recommended AGERI "develop a market-focus to guide project selection of research" and "pursue an endowment funded by USAID."

Molecular characterization of insect midgut toxin receptors for circumventing resistance to toxins of Bacillus thuringiensis by University of Wyoming/University of Texas-Dallas, and AGERI. (The partnership was with Dr. Lee Bulla, who moved during the project to University of Texas-Dallas.)

Improving quality and marketability of tomato in Egypt by AGERI.

Engineering crop plants with resistance to drought and salinity by Ohio State University and AGERI.